Responsibilities The new employee, reporting directly to the Quality Validation Coordinator, will be part of a team of 4 people. As a Quality Validation Specialist, they will play a crucial role in ensuring compliance with GMP requirements by supporting data integrity governance and equipment qualification activities. This role will contribute to maintaining the validated state of GMP systems and equipment, ensuring regulatory compliance, and supporting continuous improvement initiatives across the site. Data Integrity Ensure the implementation and ongoing maintenance of ALCOA / ALCOA+ principles throughout the entire GMP data lifecycle Support and/or perform Data Integrity Risk Assessments (DIRA) on processes, equipment, and computerized systems Evaluate and approve data governance controls, including access management, audit trails, backup, archiving, and data lifecycle management Manage data integrity deviations and incidents, including the definition and follow‑up of CAPAs Support regulatory inspections and audits as Data Integrity Subject Matter Expert (SME) Equipment Qualification Documentation Review Perform critical QA review and approval of equipment qualification documentation, including: User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Qualification reports and requirements traceability, Periodic requalification activities Ensure documentation compliance with GMP requirements, Annex 11, and GAMP 5; assess GMP impacts of change controls related to equipment and systems Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) Collaborate with other site departments to achieve the goal of the company’s projects Participate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualification Collaborate with the Engineering department to close on time all assigned projects and review all the documents prepared by the qualification team Support the Quality Compliance team in preparing customer audits and regulatory inspections, providing necessary information and documentation Specific Skills, Educational Requirements and Experience Master’s degree in industrial chemistry, Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, Biomedical Engineering or Automation Engineering Knowledge of the main ALCOA+ principles Knowledge of the key Data Integrity guidelines Strong interpersonal and communication skills Result‑oriented mindset with strong problem‑solving skills and good organizational skills Good knowledge of GMP Quality Systems Minimum of 5 years working within pharmaceutical manufacturing Strong command of the English & Italian languages; technical writing skills are a must Why Join Alfasigma At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry. #J-18808-Ljbffr